The production of investigational medicinal products is not a routine job. At the early development stages, it is unlikely to have well-defined manufacturing processes and lab analytics. Consequently, the manufacture of early phase clinical trial material supplies, requires tailored expertise.
We manufacture preclinical and clinical phase (I, IIa) materials in clean room environment. Our facility operates under GMP requirements as implemented by the Clinical Trial Directive 2001/20/EC. We bulk manufacture various dosage forms such as:
- Oral solutions and suspensions
- Powder filled capsules
- Liquid filled capsules
- Topical products
- Modified release products
- Pellets and microspheres
- Tablets
- Powders
- Overencapsulated products
Clinical Supply Material Labeling
We design and develop labels for investigational medicinal products used in open and blind clinical studies. Our services include:
- Randomization
- Translation
- Primary container labeling
- Secondary packaging labeling
- Subject kit assembly
Clinical Supply Material Release
We provide:
- Batch release according to product specification files
- Final QP release of the clinical supply materials
- Warehousing and distribution according to the Clinical Trial Supply Plan
- Import of clinical supply materials from outside the EU
Contact us for more information.
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